Citation: Trubetskaya, A.; Manto, D.;

McDermott, O. A Review of Lean

Adoption in the Irish MedTech

Industry. Processes 2022, 10, 391.

https://doi.org/10.3390/pr10020391

Academic Editor: Pietro Bartocci

Received: 1 February 2022

Accepted: 14 February 2022

Published: 17 February 2022

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processes

Review

A Review of Lean Adoption in the Irish MedTech IndustryAnna Trubetskaya 1,* , Declan Manto 1 and Olivia McDermott 2,*

1 Department of Engineering, University of Limerick, Castletroy, V94 T9PX Limerick, Ireland;declanmanto316@yahoo.co.uk

2 College of Science & Engineering, National University of Ireland Galway, H91 TK33 Galway, Ireland* Correspondence: anna.trubetskaya@ul.ie (A.T.); olivia.mcdermott@nuigalway.ie (O.M.)

Abstract: There have been many literature reviews carried out on Lean implementation in largerorganisations with specific focus on the automobile industry. Lean implementation in the medicaldevice industry has not been extensively investigated. Thus, this research endeavored to analysethe benefits of Lean, tools utilised and challenges and results of Lean implementation in Medtechcompanies. This article aims to bridge a gap in the literature by reviewing the literature that discussesLean implementation in MedTech companies in Ireland with a perspective of identifying the benefitsand challenges faced. The quantitative methodology allows us to review the comprehensive numbersand data which were collected from 20 Enterprise Ireland MedTech case studies. There are veryfew published case studies in the literature on Lean due to the highly regulated nature of MedTechsector and the vast array of medical devices, which are often under privacy and confidentialityconstraints. The results showed that integration of Lean has brought benefits to companies byincreasing productivity and product quality, optimised cost, and time. An inclusive discussion ofLean tools for Lean implementation within MedTech was established and suggestions for futureresearch orientations are thus provided.

Keywords: Lean; medical device industry; Ireland; supply chain management

1. Introduction

Various industries have seen, over recent decades, massive improvements to manufac-turing processes due to the application of the Lean methodologies [1]. Heavily regulatedindustries such as medical technology (MedTech) and Pharmaceutical Manufacturing havebeen slow to adopt and implement Lean strategies [2]. In the medical device and phar-maceutical industries, which are highly regulated to assure patient and customer safety,continuous improvement programs can face many challenges [3]. Due to the regulatednature of the industries, medical device manufacturing focuses on quality, and for goodreason, though this means little time is left to remove the sources of waste. It is criticallyimportant to have all released products be 100% compliant with all specifications andunderstand all factors which have a strong impact on the improvement of Lean strategiesin MedTech to remain a competitive industry [4].

Ireland has gained tremendously from this high-growth industry and currently em-ploys over 40,000 people within this sector [5]. Ireland has been identified as a desirablelocation for MedTech companies as 9 of the world’s top 10 MedTech companies have locatedtheir manufacturing facilities here [6]. Ireland is seen as a high-cost manufacturing locationmainly driven by high cost of labour, property, transportation, and utilities [7]. Despite all ofthis, Ireland is globally recognised as being competitive in a range of sectors including food,medical devices, pharma/biopharma, ICT, engineering, and green technologies [8]. Dueto the thriving success of the MedTech industry, organisations in Ireland are increasinglytransitioning to the adoption and deployment of Lean methodologies with the objectiveof driving new and innovative technology, delivering on new product development, andlooking to improve operational efficiency and product quality [9]. The MedTech companies

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based in Ireland are hugely reliant on large multinational enterprises and form part of a vastnetwork of suppliers who provide products and services to these customers. Irish-ownedcompanies in Ireland are considerably smaller in terms of scale and the higher proportionof exports is delivered by foreign enterprises, which requires the development of a supplychain network that is different from other EU countries. The MedTech network in Irelandvery often uses the contract manufacturing business model, in which a medical devicecompany outsources partial or entire manufacturing of their medical device or servicesto another company with specialised knowledge and technical expertise. The customerconstantly demands excellent operational performance from MedTech. Therefore, thesurvival of MedTech in this competitive environment strongly depends on the continuousimprovement of the operational performance [10]. The roots of continuous improvementmethods such as Lean did not originate within the MedTech industry. The automotiveindustry is responsible for the birth of Lean production. Henry Ford revolutionised thisindustry by focusing on interchangeable parts and implementing the first moving assemblyline. The primary goal of Lean is to eliminate or reduce waste, with waste being anythingthat adds no value in the eyes of customers. Womack et al. (1990) defined Lean thinkingas “a way to do more with less and less human effort, less equipment, less time, and lessspace while coming closer to providing customers with what they want” [11]. Principlesof Lean are adding value, creating flow, and establishing pull in pursuit of continuousimprovement and putting the customer first [12,13]. Lean focuses on non-value-addedwaste elimination, including the seven waste types of transport, inventory, motion, waiting,over-production, over-processing, and defects, which is particularly vital in helping addvalue and improving flow in an operation [14]. The success of Lean integration stronglydepends on the selection of tools. One of the Lean tools is a value stream map (VSM) thatshows the steps of the workflow process and further can help to identify and eliminatethe Non-Value Add (NVA) and reduce delays. This supports the quality improvement ofproduct and services. Creating a continuous flow to the customer would play a significantrole in optimising the process efficiency by enabling a continuous flow of the product andservices [10]. Various other lean tools may include; Kaizen, which emphasises continuousimprovements by focusing on the minor improvements; Just-in-time, which meets thecustomer demands that flow from the customer; SMED, which minimises the changeovertime; Poka-Yoke, which issues alerts on failures and defects; Jidoka, which ceases theproduction or assembly line during defect; Gemba, seeing the problem at the source; andKanban, which manages the inventory levels [15]. All of these tools would ensure that theLean approach reduces the cycle time of the business process, improves the service deliveryor product time, reduces the inventory levels and defect generation chances, and optimisesresource utilisation.

There are many Lean tools, which can be grouped into sections: waste minimisation,flow improvement tools, and new layouts. The selection of tools strongly depends onthe desired improvements from basic work to entire line engineering and includes thefollowing tools (Table 1).

Aside from the fact that Lean systems (LS) did not originate within the MedTech indus-try, this sector operates under a very stringent regulatory regime to ensure that its productsare safe to use on their customers, many of whom are based in healthcare settings [16].Globally regulatory bodies such as the European Medicine Agency (EMA) and the US Foodand Drug Administration (FDA) amongst studies place stringent requirements on MedTechcompanies to ensure product safety in the design, manufacture, and use of medical devices.Depending on what countries a MedTech company exports to, the company may have tomeet the regulatory requirements of several global jurisdictions. An Irish manufacturerexporting into the USA and Europe must adhere to both the FDA and EMA regulatory re-quirements. A robust and detailed Quality Management System (QMS) must be maintainedwithin any company operating under these regulatory requirements. This is, of course,beneficial for a company to work towards these requirements and achieve the standards setout by global regulatory agencies. Adhering to regulations can create difficulties internally

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for a company trying to introduce new programs or methodologies such as Lean [17]. Thefocus on regulatory compliance makes it more difficult to make internal process changesonce a product has already been approved for commercialisation, and as a result, cre-ates obstacles in the implementation of Lean programmes within MedTech particularlyin smaller and mid-sized companies (SME’s) [18,19]. Larger MedTech companies tendto have more success in deploying such programs [20,21]. Case-study examples in thissector have been collected by Lean Business Ireland [22] and demonstrate that the commonchallenge companies face when trying to implement a Lean or Six Sigma strategy is witha constraint of resources. Naturally, larger companies are better positioned to overcomethis obstacle, so it makes sense that these programmes have a higher probability of successwithin these organisations. Alternatively, SME companies choose to adopt Lean tools,which best fits the issues that need to be addressed and what needs to be improved withinthat company, i.e., productivity, quality, and process focus [18,21]. This approach can alsoyield successful outcomes but does not realise the full capabilities of Lean by only focusingon processes and output versus building a culture of continuous improvement withinthat organisation [23]. Due to ever-growing competition in today’s manufacturing sector,many companies are using continuous improvement as a change management disciplineto help their companies become more competitive [24]. These improvements are achievedby using the right tools and techniques targeted at identifying and removing waste andvariation in business processes of all sizes [25]. The concept of continuous improvementcomes under many different guises, most notably continuous improvement itself, but italso encompasses enterprise excellence and Lean manufacturing and Lean systems [26].Much of the literature covers Lean implementations mainly in the manufacturing sectoras the origins of Lean lie therein [18]. However, it is also evident that Lean can also bringsignificant benefits in transactional environments [27–29]. While much of the literaturerefers to Lean in large organisations and how it should be adapted to suit SMEs, there islimited research into deployment within the MedTech [18,19].

Table 1. Lean tools (author constructed).

Lean Tools Description

Waste minimisation tools Many forms, e.g., inventory, waiting, over-processing

Value Stream Mapping A map of the entire value chain, identifying all the activities involved in theproduct from start to finish

Value-added analysis Identify value in the eyes of the customer and categorise into value added,non-value added, and non-value by required

5S house keeping Tool to organise a workplace, establish standardised conditions, and maintain thediscipline that is needed to do this job.

Flow improvement tools Allowing customer to pull value when needed.

One-piece flow Work-in-progress eliminated, allowing flow through the value chain.

Kanbans Signal to internal processes to provide a product. Used with pull systems.

Pull production Manufacture of product as customer wants it.

Total Productive Maintenance Machinery performing with zero breakdowns and high quality.

Poka-yoke (error proofing) A mistake-proofing procedure or device designed to prevent or detect errors.

Single Minute exchange of Dies (SMED) A series of technologies to allow for rapid changeovers of production machinery.

Just in Time principles Producing and delivering the right items in the right time in the right amounts

Layout improvements Can range from basic work step improvements to entire line reengineering.

Flow charts Graphical representation of process sequences.

Line balancing Alignment of work steps aiming to minimise process delays and fluctuations withproduction levels.

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The MedTech sector is generally perceived as averse to risk and change [30,31]. Intheir paper on MedTech design process improvement, Boylan et al. [32] also discussedtheir objective of improving the process without invoking extra regulatory approval andoversight. Regulatory compliance is perceived to be a barrier that stifles innovation andcontinuous improvement within the industry, significantly limiting the scope for designchanges and innovation and especially changes once launched [33,34]. Parallels can bedrawn with other heavily regulated manufacturing industries, such as aerospace and phar-maceutical drugs [35]. A focus on regulatory compliance and quality management is oftencited as an impediment to Lean and other continuous improvement tools in the MedicalDevice industry [36]. Even in organisations where continuous improvement systems aredeployed, they remain secondary to the dominant regulatory quality system, e.g., ISO13485:2016 [18]. When comparing the international standard for Quality ManagementSystem ISO 9001:2015 with the corresponding equivalent standard for the medical deviceindustry, ISO 13485:2016, the section on continuous improvement is a noteworthy omissionfrom the medical device standard in an otherwise harmonised pair of standards [37]. Thereis greater scope to make changes to non-manufacturing processes and transactional pro-cesses in a medical device organisation, such as changes to the New Product Introduction(NPI) process, administrative, warehousing, and logistics.

The success of Lean in Irish MedTech is well documented, with many companies receiv-ing prestigious accolades in this area and transforming Ireland into a globally recognisedhub of excellence [22]. The uptake of organisational excellence and process improvementmethodologies has been accelerated by the greater scrutiny from regulatory bodies andagencies in different global jurisdictions to demonstrate the cost/benefits of medical deviceproducts [36]. However, global regulatory authorities’ evolving marketing and regulatoryrequirements necessitate constant monitoring of each regulatory jurisdiction by manufac-turers [38]. Fear of upsetting regulatory authorities also can lead to a fear of implementingprocess changes least compliance be affected. However, there is potential to use LeanSystems in the Irish MedTech industry as Lean has been shown to drive improvements toboth cost and lead times [39].

The previous studies have shown the potential of operational excellence tools to launchnew medical devices and technologies at a faster pace by integrating the knowledge onLean Systems in MedTech [40,41]. To the authors’ knowledge, this review article is the firstwork that discusses the application of lean in transactional and service processes of theIrish MedTech.

The research objectives for this research are to study Lean deployment and imple-mentation in Irish Medtech. The researchers also seek to ascertain the reasons for imple-mentation, understand what type of Lean tools are most utilised and if different to otherindustries, and what benefits and results are observed. As previously mentioned thereis a dearth of literature related to Lean deployment in Irish Medtech and in Medtech ingeneral [18,19,32,36].

This work aims to show the enormous potential for improvement to both cost andlead times through the literature review around Lean deployment and the factors thatcan influence successful deployment within the MedTech. Section 2 outlines the researchmethodology, while Section 3 elucidates on the results. Finally, Sections 4 and 5 containsthe discussion of the results and conclusion.

2. Review Methodology2.1. Methods

This section describes the research approach followed in this study. Secondary researchwas utilised to review the quantitative and qualitative results of case studies with themain aim to assess the impact Lean deployment has had within the Irish MedTech sector,including benefits and challenges which the organisations faced. The results of case studiesconducted in 19 medical device organisations in Ireland, involving MedTech employeesfrom private sectors in a period of 6 years were reviewed. The available lean tools were

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discussed, then the importance of a company size for the selection of Lean strategies, andlean tools used specifically in the MedTech organisations including challenges and benefitsof tools’ use. In this review article, the published case studies were reviewed, and the resultswere related to the recent literature on the digital transformation in MedTech followed bydiscussion and conclusion sections.

2.2. Case Studies

An exploratory study of literature and a documented case study database was carriedout to conduct the current research work. The government of many countries worldwide areencouraging and helping small- and medium-scale industries understand and implementlean systems by preparing an accessible database of Lean consultants, providing financialassistance for training by professionals, and establishing professional associations [42,43].This approach has been well documented through case studies provided by Lean BusinessIreland via structured interviews and quantitative data gathered by participants [22] thatthere is growing uptake of Lean from MedTech companies who have had little exposure orexperience with this philosophy. Multiple case studies published by Enterprise Ireland onLean deployment initiatives in 19 MedTech companies were studied. These case studieswere made up of structured interview commentary and quantitative date collection fromparticipants in the Enterprise Ireland Lean program. The reasons for the Lean deployment,the benefits of the Lean deployment, and the results and challenges to Lean deploymentwere all studied, and the types of Lean tools used. The case studies reviewed were selectedbased on company size directly linked to different companies in MedTech in differentlocations across Ireland, as shown in Table 2.

Table 2. Lean Case Study Organisations reviewed from the Irish MedTech Industry (location andsize) (author constructed).

Case Study Organisation Organisation Size Location

#1 Medium (50–250 Employees) Southeast#2 Small (10–50 Employees) Southeast#3 Small (10–50 Employees) Southeast#4 Large (250+ Employees) Southwest#5 Large (250+ Employees) East#6 Small (10–50 Employees) Southwest#7 Small (10–50 Employees) Northeast#8 Large (250+ Employees) West#9 Large (250+ Employees) Southeast

#10 Large (250+ Employees) Mid-West#11 Small (10–50 Employees) Southwest#12 Large (250+ Employees) Mid-West#13 Medium (50–250 Employees) Midlands#14 Small (10–50 Employees) Mid-West#15 Large (250+ Employees) Southeast#16 Large (250+ Employees) Southwest#17 Large (250+ Employees) Mid-West#18 Large (250+ Employees) Mid-West#19 Large (250+ Employees) Southwest

2.3. Company Size

87 MedTech companies are operating in Ireland as of 2020 [43,44]. Within this study,of the 19 MedTech companies reviewed, 58% (11) were large enterprises (LEs), 32% (6)were small enterprises (SEs), and 10% (2) were medium enterprises (MEs). Generally, inthe literature, it is recognised that LEs have more success with Lean implementation dueto having more extensive resources at their disposal [45,46]. Extensive research carriedout by Eatock et al. [47] demonstrates that changes to a product type or technology withinthe MedTech industry can impact the level of success and Lean strategies deployed. This,coupled with company size from a micro-sized to a large company, also pivots the approach

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towards specific methodologies versus others [48]. The types of medical devices beingmanufactured, and their classification must also be considered as it drives many pre- andpost-market regulatory requirements. The higher the classification of a device, the higherthe risk of the device in use and, therefore, the more significant the safety and regulatorycontrols required of the manufacturer and within the manufacturing processes. In the USA,for example, Class I devices are deemed to be low risk and are subject to minor regulatorycontrols, e.g., dental floss is classified as a Class I device [49]. The MedTech companiesinvolved in this study ranged from manufacturers of Class 1, the lowest risk classificationdevices, to Class III, the highest risk, with some making several types of devices. This meansthat there may be several manufacturing “factories” within one manufacturing factory.

3. Results3.1. Reasons for Undertaking a Lean Initiative

With the ever-growing competition in today’s manufacturing sector, many MedTechcompanies are using continuous improvement as a change management discipline tohelp them become more competitive. These improvements are achieved by using theapplication of tools and techniques targeted at the identification and removal of waste andvariation in all business processes. The main reason that companies implement continuousimprovement is to improve their performance, increase their profitability and create acompetitive advantage [50]. These efforts can seek ‘incremental’ improvement over variousperiod of time or ‘breakthrough’ improvement all at once. The concept of continuousimprovement comes in many different guises, most notably continuous improvement itselfbut it also encompasses enterprise excellence, lean manufacturing, and lean systems aimingto improve competitiveness and performance of an enterprise [4].

Within the case study, MedTech organisations who participated in the Lean Irelandprogram funded by Enterprise Ireland listed their critical reasons for starting on a Leanjourney or continuing an existing one as outlined in Table 3, with many themes being listedmore than once. Nearly all of the reasons given by the MedTech organisations were alongwith the themes of improving production line layout and flow, improving work-in-progress(WIP), standardising processes, improving productivity, and improving quality. Reducingwaste and cost savings were also cited by almost all the MedTech case study organisations.Some of the reasons stated directly for implementing Lean were “The main objective is cost;current cost exceeds the budgeted cost” and “maintaining our ability to meet customer demand”as well as to “to enhance a Problem-Solving Culture”. These results align with benefits ofcontinuous improvement were observed across other industrial sectors such as automobileand pharmaceutical manufacturing [51].

Table 3. Key reasons for Lean initiative deployment in Irish MedTech organisations (author constructed).

Key Reasons Detailed Explanation

Improve layout and flow Just-in-time that meets the customer demands that flow from the customer

Supply Chain Enhancement Active supplier involvement and management

Reduce Waste Reduce non-value adding process steps, often mentioned in the literature asthe 8 forms of waste

Improve Productivity Productivity boost through operations strategy and network optimisation

Expedite Operations Expedite the time to market of medical devices

Improve Quality A strong focus on quality and eliminating causes of defects by participation in improvementinitiatives and problem solving

Standardise Processes Standardisation and ‘6S’ practices, resulting in continuous improvement

Improve Competitiveness Improvement of performance in competitive priorities such as quality, reliability, and speed

Work-in-Progress Reduction Reduce unnecessary early start in a push-pull and pure push system

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Lean strategies enable the MedTech companies to develop and deliver high-qualityproducts and services faster and with less waste. Lean thinking can be effective in anyindustry, i.e., automobile, pharmaceutical, etc. However, MedTech companies can obtainsignificant competitive advantages in the areas of development, production, and supplychain through the implementation of Lean deployment strategies. The key reasons forLean initiatives deployment in MedTech is to “improve productivity, expedite manufacturingoperation” by bringing the product on the market rapidly and making the products “compet-itive”. Toyota’s lean product development process can provide a MedTech company withthe ability to beat its competitors to market with products that better meet the needs of itscustomers. If a medical device manufacturer can shorten its internal production lead times,two key benefits will result, such as more investment into development or into acquisitionsand possibility to mass customisation. Lean strategies can help a medical device companyto improve “supply chain management”. Most medical device companies are not verticallyintegrated, but lean supply chain methodologies can be used to shorten supply chainlead times and ensure better quality. The utilisation of lean strategies will also result indevelopment of more reliable and “higher-quality products as well as its delivery/lead-timeand cost. Instead of increasing the number of inspection stations, a lean medical devicemanufacturer would utilise true root cause analysis problem-solving to eliminate the causesof defects. With the increased demand of medical devices in the COVID-19 crisis, it isespecially important to ensure timely delivery, customer satisfaction and minimisationof delays. A “continuous flow” with no interruptions, no batches and inventories, and noqueues and wasted motions is a key reason to integrate Lean tools in the MedTech. In acontinuous flow layout, workers perform much more value-adding work and can moreeasily see the results of this work, which provide them with a sense of accomplishmentand satisfaction from the work. Concurrently, “work-in-progress” should be minimised tokeep the production cycle optimal with respect to the quality, cost, and productivity. Bythe development of key Lean parameters, MedTech companies will be able to standardiseprocesses and services in the complex and vast network of suppliers and customers.

3.2. Lean Tools and Principles Utilised by Irish MedTech Organisations

The Lean tools and principles which were cited as utilised in each of the IrishMedTech organisations who participated in the case studies are shown in Table 4. VisualManagement and Non-Value Add (NVA) waste analysis, 5S, Value Stream Mapping(VSM) and introduction of Key performance indicators (KPIs) were the most commonlyutilised tools. It should be noted that depending on the organisation’s size, there was adifference in the level, usage, and application of Lean tools. There was more utilisationof several Lean tools in the LEs as compared to the smaller ME and SE organisations.The smaller and medium-sized enterprises utilised one or two main Lean tools, whereasthe larger ones utilised more of a suite of Lean methods. KPIs, visual management,and visual management boards were applied consistently throughout all participat-ing organisations, as they are foundational lean tools. Tortorella and Fettermann [52]discussed the importance of evaluating the deviations registered in the visual manage-ment and KPI production boards in driving actions that were not implemented in thedaily routine whenever needed, registering comments and observations, and observingproblems and improvements in the production flow.

There are other less-popular tools mentioned in the Lean literature that includes:5 Whys; Small Lot Sizing and Single Minute Exchange of Die; Level scheduling; andKaizen [8]. These tools are seen to be less popular among SME companies due to theircomplexity and high cost [53–55]. Despite this fact, there is very little in the literature thatdiscusses the justification or motivation for the selection of specific Lean tools in SMEs andlarger MedTech enterprises.

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Table 4. Lean Tools and Principles deployed within Irish MedTech.

Case Study Organisation Lean Tools/Principles Deployed

#1 KPI’s, 5S, Kanban, Visual Management#2 KPIs#3 Process Mapping#4 Visual Management#5 Process Mapping, NVA Analysis#6 OEE analysis#7 5S, Visual Management#8 Process Standardisation, NVA Analysis#9 Defect reduction, NVA Analysis, Kaizen, VSM

#10 POC VSM, Yamazumi Charts#11 Brainstorming, Affinity Diagrams, FMEA, Visual Management#12 KPIs, Visual Management#13 Standardised work, SMED, 5S#14 Visual Management Boards, DFSS, 5S, NVA Analysis#15 VSM, Process Mapping, Kaizens, DMAIC, A3 Problem solving#16 VSM, Kaizens, KPIs, Gemba#17 KPIs, Visual Management#18 Standardised Process#19 5S, Kanban, SMED, Standard Work, TPM, A3 Problem solving

3.3. Challenges to Lean Deployment within Irish MedTech

Achanga et al. [54] suggested that the implementation of LM, as with any otherproductivity improvement initiative, is believed to harbour enormous difficulties andchallenges. Challenges were highlighted regarding Lean deployment by the case studyof MedTech organisations. The key challenges identified centred around “lack of resourcesfor Lean projects and deployment”, “lack of Lean knowledge”, “Lack of training”, “trying tocreate a culture for change and CI in the organisation” and “lack of alignment of metrics withstrategic objectives”. The organisations involved did not expand as elaborately and in asmuch detail on the type of challenges as they had in Lean deployment compared to thedetail given on other areas of the Lean deployments. Extensive research carried out byAlbliwi et al. [55] shows that a lack of financial or physical resources has been cited as acritical failure factor for Lean deployment, as was poor organisational capability. Resistanceto change is a standard feature found in most companies when trying to change theirmethods, and smaller, under-resourced organisations struggle more to try and overcomethis challenge [56].

Poor organisational readiness and lack of management commitment for Lean trans-formation has also been seen as the main obstacle to Lean success [55]. As it is part of abroader cultural change, the involvement and commitment of intermediate leaders andsenior managers are fundamental for Lean efficacy [57]. As management approached Enter-prise Ireland for support with their Lean deployment programs, lack of commitment andsupport was not a factor in this study. However, it is unknown as to the levels of supportand momentum sustaining the Lean initiative by management teams once initial trainingand Lean consultants sponsored by Enterprise Ireland had moved on to other organisations.Shrimali and Soni [58] proposed that an effective method to break down this barrier isto establish workshops, presentations, and belt programs within the company. They alsosuggest that the training should be structured in a way that is relevant to employees’ jobs.Another option to improve the Lean culture in MedTech organisations is to combine Leantechniques with Sigma Six strategies [1]. This could provide a more integrated and coherentapproach to reduce cost, make deliveries on-time, and minimise both inventory and cycletime [59,60].

The COVID-19 crisis have caused radical changes in the tools and production pro-cesses of medical devices and services used by people. The novel production methodsand lifestyles are in process to be formed by transforming the communication tools and

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production systems used. Increasingly sophisticated and complex products, combinedwith more stringent regulatory requirement require the MedTech companies to embracedigitalisation to remain competitive. Industry 4.0 focuses on improving process efficiencyto deliver high-quality products at lower costs. The Industry 4.0 platform can stronglyinfluence productivity through increased automation, more intelligent control of planning,logistics, maintenance and purchasing, optimised supply chains, improved traceability, andestablishment of new delivery platforms [61]. Thus, the data collection and integration intoIndustry 4.0 platform, communication, and education of MedTech companies will boostlean systems framework [62].

3.4. Results of Lean Deployments

In terms of the results of Lean deployment in the case study organisations, therewere several quantitative and qualitative benefits put forward by participant MedTechorganisations. In terms of quantitative benefits, improved productivity, reduced waste,cost reduction, improved quality, and elimination of customer complaints were all listed.However, from an organisational point of view, several other resulting benefits wereverbalised, including increased employee engagement, improved organisational culturefor problem-solving, education in Lean and continuous improvement, improved teamengagement and alignment with strategic objectives, to name but a few. Extensive researchcarried out by Eatock et al. [47] demonstrates that changes to a product type or technologywithin the MedTech industry can impact the level of success and Lean strategies deployed.This, coupled with company size from a micro-sized company to a large company, alsopivots the approach towards specific methodologies versus others [48]. The main resultsfrom case studies are summarised in Table 5.

Table 5. Results of Lean Deployments in Irish MedTech case study organisations.

Case Study Organisation Results of Lean Deployment

#1 The warehouse capacity was increased by 27% completely alleviating the bottleneck. Warehouse capacitynow visible and in real-time.

#2 We devised an operational dashboard, identified targets and metrics to showwhat successful outcomeswould look like. We increased Gross Profit by 200% during a 6-month period.

#3Engagement with the concept of Lean resulted in improved staff morale, increased engagement within theteam, and an overall better understanding of how day-to-day activity can help to achieve the overallbusiness objectives and vision.

#4 10% Productivity Improvement

#5 Improved culture

#6 Increased productivity by 20 units per week on one line that yielded an extra gross contribution of EUR63,000 per annum for the company.

#8

• Process stabilisation 10–15% year on year productivity improvement in Key Value Streams.• 10–20% reduction in scrap within key value streams.• Organisational structure development.• Cultural change and employee engagement.

#9

• Batch review and release time has reduced by over a third• Elimination of non-value-add activities in the collection, transcription and checking of a large

number of data points for each batch of product

#11 A key result was the development and operation of Lean production scheduling visual boards as the basisfor New Products being introduced to a developing productionsystem.

#12 Improvement areas identified that were addressed resulted in cost reductions of EUR 120,000 per year; andthe dashboard is now playing a key role in measuring the effectiveness of future improvement projects

#13 Result—9% increase in overall output and revenue saving of EUR 160,000 per annum

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Table 5. Cont.

Case Study Organisation Results of Lean Deployment

#14 Elimination of waste (defects) from volume production lines, elimination of customer complaints.

#16

Huge shift in culture especially at associate level—empowered to do their job betterEliminated Non-Value-Add activities such as manual collection, collating data in Excel, producingreports etc.ROI in Excess of 200% within 12 monthsOverall Increased Efficiency 7%Increased Output 5%Scrap reduction across the value stream <40%Reduction in WIPIncreased Equipment Utilisation—from 80–85%Increased Schedule Attainment—from 90–96%

#18• Made visible the invisible–COPQ was 4x larger than original estimates• Enabled COPQ reduction activity in excess of EUR 10 million

#19• Company embraced A3 as problem solving methodology.• Trained all 130 staff in how to use A3.

The results presented in Table 4 indicated that the dominant objectives for Lean Deploy-ment in the MedTech companies are reduction of waste and cost, increase of productivity onthe production floor and improvement of organisational culture. The case studies show thatLean Deployment is predominantly introduced successfully in large corporations, howeverthis concept should work in any size business. This is due to the nature of Lean systemsthat depends upon characteristics inherent to any business, not on the size of the businessitself. Of course, SMEs have constraints that limit their ability to initiate a large-scale LeanDeployment, such as the finances and resources to train staff and implement Lean supportstructures across the full organisation, but there are ways to overcome these limitations.The financial and cultural transformation benefits that stem from Lean Deployment shouldpropagate more quickly through a SME due to its small size. Focusing the Lean tools atany properly scoped project should deliver savings to the bottom line while achievingbreakthrough change. In case study 14, driving cost and waste out of the business is seenas a critical part of the business and using Lean systems should help achieve this. Incase study 16, there are 9 criteria which is more difficult to achieve, but the integrationof Industry 4.0 platform could support the MedTech company in this transition. UsingLean Deployment fits the enterprise excellence strategy which is to continually improveprocesses and empower everyone to solve problems. The high-performance culture pillaris about growing and developing people to achieve superior results, innovation, and speed.It is also about finding creative ways to do things better and faster, whereas voice of thecustomer is about delivering what the customer wants. The Lean Deployment across theMedTech site can support all these strategic plans.

4. Discussion

The MedTech industry in Ireland spans the entire country and brings a rich and largenumber of companies which are based in Cork, Galway, Dublin, and Limerick. Such agrowing industry also brings with it a diverse range of company types, sizes and productsand services that they offer. The most noticeable differences of MedTech sector to otherindustries is based on the burden of regulatory requirement which companies must followand a vast of products and services which MedTech companies offer. The various sizes ofMedTech companies and complex network of supplier and manufacturing plants are themain contributing factors in the Lean Deployment. The Lean tools used by Irish MedTechcompanies are summarised as a part of the Toyota production system in Figure 1.

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whereas voice of the customer is about delivering what the customer wants. The Lean Deployment across the MedTech site can support all these strategic plans.

4. Discussion The MedTech industry in Ireland spans the entire country and brings a rich and large

number of companies which are based in Cork, Galway, Dublin, and Limerick. Such a growing industry also brings with it a diverse range of company types, sizes and products and services that they offer. The most noticeable differences of MedTech sector to other industries is based on the burden of regulatory requirement which companies must follow and a vast of products and services which MedTech companies offer. The various sizes of MedTech companies and complex network of supplier and manufacturing plants are the main contributing factors in the Lean Deployment. The Lean tools used by Irish MedTech companies are summarised as a part of the Toyota production system in Figure 1.

Figure 1. Toyota production system (TPS) of MedTech companies.

The goal of the Toyota production system is to obtain products of the highest quality in the shortest lead time and at low cost. SME companies will use only some of the Lean tools due to the limitation of resources and finances. However, the results of this review indicated that the integration of Lean tools depends on both production system goals and organisational culture. Lean is embraced despite the strict regulatory regime surrounding the MedTech industry. Just-in-Time and Jidoka concepts have been successfully used in large MedTech companies, but several case studies also showed promises to deploy all mentioned Lean tools to continuously improve organisational culture and manufacturing.

The results and changes highlighted from Lean deployment were generally more to do with standardised work, improved line layout and elimination of non-value-add steps. The Lean tools used in the MedTech sector are not different from other industries.

There are many tools which can be grouped into sections: waste minimisation tools, flow improvement tools and new layout tools. The selection of tools strongly depends on the desired improvements from basic work to entire line. Moreover, none of these changes utilising basic Lean tools such as 5S, standardised work, process mapping, Kaizen, and NVA analysis would require substantial manufacturing changes or process and equip-ment validations.

Figure 1. Toyota production system (TPS) of MedTech companies.

The goal of the Toyota production system is to obtain products of the highest qualityin the shortest lead time and at low cost. SME companies will use only some of the Leantools due to the limitation of resources and finances. However, the results of this reviewindicated that the integration of Lean tools depends on both production system goals andorganisational culture. Lean is embraced despite the strict regulatory regime surroundingthe MedTech industry. Just-in-Time and Jidoka concepts have been successfully used inlarge MedTech companies, but several case studies also showed promises to deploy allmentioned Lean tools to continuously improve organisational culture and manufacturing.

The results and changes highlighted from Lean deployment were generally more todo with standardised work, improved line layout and elimination of non-value-add steps.The Lean tools used in the MedTech sector are not different from other industries.

There are many tools which can be grouped into sections: waste minimisation tools,flow improvement tools and new layout tools. The selection of tools strongly dependson the desired improvements from basic work to entire line. Moreover, none of thesechanges utilising basic Lean tools such as 5S, standardised work, process mapping, Kaizen,and NVA analysis would require substantial manufacturing changes or process andequipment validations.

The changes mentioned above would be basic and would not affect product function-ality and safety and thus require notifications and submissions to the regulatory authorities.The majority of the changes to layout, standardised work, implementing visual man-agement, problem-solving, and KPIs had more of an effect on employee morale, teamengagement, training, and enabling problem-solving and generating a culture of contin-uous improvement (CI). Compliance with the approved QMS was also unlikely to beaffected, nor would the original regulatory authority approvals. Another important resultin this review is related to the opportunity to deploy similar Lean tools in MedTech organi-sations of various sizes. While there were more SMEs than LEs and SEs in this study, thereseemed to be common benefits, results, tool usage, and reasons for deploying across allthe organisational sizes. However, the Lean tool suite was a broader deployment withinthe participating LE organisations, which is understandable given their more significantshare of resources. As Enterprise Ireland aided these organisations with supporting Leandeployment, it was not surprising to see more SMEs involved as many larger Irish LE

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MedTech organisations with US-based parent companies already have their own Leaninitiatives and did not require Enterprise Ireland support.

The abundance of products in the MedTech creates complexity as patterns of demandshift, companies need to consider where their future growth is likely to come from andadjust their suppliers’ network according using selected Lean tools. MedTech companiesare highly regulated where changes in legislations occur frequently and thus, requiring fastrespond from the industry. Concurrently, quality and cost of products must be maintainedto be optimal. The combination of customer’s demand and MedTech product propertiesmust be balanced to avoid risks. Managing risk is an essential enterprise requirementacross industrial sectors [63]. From the perspective of well-established governance withincompanies, the ability to understand, define, assess, and implement preventive measuresto avoid the risk is a main driver in the risk-management framework [64]. The relationshipbetween the processes of risk identification, evaluation, and management formulatesthe risk management framework. There might be a number of significant risk-relatedchallenges to the MedTech project. When a new technology is being introduced, from aregulatory compliance perspective a risk assessment must be performed to ensure therewill be no risk to the patient and healthcare staff. It will additionally require support andapproval form the senior management. There can be also a business risk that is associatedwith the potential inability to meet forecasted customer demand. New digital tools forthe handling of risks related to MedTech supply–demand management could potentiallyreduce pressure on both government authorities and businesses concurrently, preventingfinancial challenges and environmental damages and promoting a mindset change at thecorporate and individual levels [65]. Industry 4.0 consists of advance manufacturing andinformation technologies for the fulfilment of the customised requirement and minimiserisks in MedTech companies [66]. These technologies provide wireless connectivity inthe MedTech manufacturing and service sector to enhance automation. The previousstudy on the integration of digital technologies in the MedTech industry identified fivemain surveyed barriers, which were ‘Manufacturing Process’, ‘Medical and Professional’,Medical Device Reimbursement’, ’Material Issues’, and ‘Staff Training’ [67]. These barriersmust be addressed during workshops and trainings to attempt four opportunity areas—material science, technology, business models, regulations and quality management—where digital technologies can be integrated. Further investigations and new case studiesaround these four opportunities will disclose the practice–technology relationship andunlock the potential of Industry 4.0 use in the MedTech. This will benefit to the potential ofengagement of new entrants to the MedTech industry, incumbent firms, health care system,and patients in Europe.

5. Conclusions

The novelty of this review article relies on the fact that the Lean tools utilised in theMedTech companies did not show significant differences to other industrial sectors. Thisis novel, as there has been a dearth of studies on Lean in the Medical device sector andthis study adds to the state of the art. Moreover, due to the fact that the sector is highlyregulated, which makes change difficult, this study proves that Lean can be deployedsuccessfully in this sector.

Despite continuous improvement initiatives being more difficult in MedTech due to thevast number of available products and the heavily regulated nature of the MedTech sector,a number of Lean tools in combination with the improvement of organisational culturecan be used. Larger MedTech companies are better equipped to plan and forecast the levelof expertise, market demand, training and specific tools required by staff to continuouslyimprove manufacturing. Small and medium-size MedTech companies were seen in theliterature as organisations which integrate a specific set of Lean tools in dependency onthe strategic business plan. This review showed that companies of various sizes mustalign metrics with strategic objectives prior their selection of specific Lean tools. Thecomplexity of the supply–manufacture–customer network in Ireland creates additional

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challenges to the integration of Lean tools in MedTech. The implication for practitioners inthis paper is related to the active integration of digital tools such as Industry 4.0 to makethe selection of Lean tools and strategies automatic based on the experiences of variousMedTech companies in Ireland. The further penetration of digital tools into MedTech willbenefit quality, cost, organisational culture, and the environment. This review identified alack of studies related to consideration of sustainability in MedTech manufacturing. Thecomparison of Lean deployment in Ireland with other EU countries is another limitationthat can be further investigated.

Author Contributions: Conceptualization, A.T., O.M.; methodology, A.T., O.M.; software, A.T.;validation, O.M.; formal analysis, A.T., O.M.; investigation, O.M.; resources, D.M.; data curation,D.M., A.T., O.M.; writing—original draft preparation, A.T., O.M., D.M.; writing—review and editing,O.M.; visualization, A.T., O.M.; supervision, A.T., O.M.; project administration, D.M.; fundingacquisition, O.M. All authors have read and agreed to the published version of the manuscript.

Funding: This research received no external funding.

Institutional Review Board Statement: Not applicable.

Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.

Data Availability Statement: Not applicable.

Conflicts of Interest: The authors declare no conflict of interest.

Abbreviations

CI Continuous ImprovementCOPQ Cost of Poor QualityDFSS Design for Sigma SixDMAIC Define, Measure, Analyse, Improve, ControlEMA European Medicine AgencyFDA Food and Drug AdministrationFMEA Failure Modes and Effects AnalysisICT Information Communication TechnologyKPI Key Performance IndicatorLS Lean SystemsMedTech Medical TechnologyNPI New Product IntroductionNVA Non-Value AddOEE Overall Equipment EffectivenessPOC Proof of ConceptQMS Quality Management SystemSME Small and Mid-sized EnterprisesSMED Single Minute Exchange of DieTPM Total Productive MaintenanceTPS Toyota Production SystemVM Visual ManagementVSM Value Stream MappingWIP Work-In-Progress

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